Trials / Recruiting
RecruitingNCT07196501
A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 550 (estimated)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NBI-1065845 | Oral tablet |
| DRUG | Placebo | Oral tablet |
Timeline
- Start date
- 2025-08-18
- Primary completion
- 2028-07-01
- Completion
- 2028-07-01
- First posted
- 2025-09-29
- Last updated
- 2026-03-19
Locations
45 sites across 11 countries: United States, Australia, Bulgaria, Canada, Estonia, Italy, Poland, Serbia, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07196501. Inclusion in this directory is not an endorsement.